- Email: [email protected]
Results of the Scoliosis Research Society Morbidity and Mortality Database 2009–2012: A Report From the Morbidity and Mortality Committee
Spine Deformity 4 (2016) 338e343 www.spine-deformity.org
Results of the Scoliosis Research Society Morbidity and Mortality Database 2009e2012: A Report From the Morbidity and Mortality Committee Douglas C. Burton, MDa,*, Brandon B. Carlson, MDa, Howard M. Place, MDb, Jonathan E. Fuller, MDc, Kathy Blanke, RNd, Robert Cho, MDe, Kai-Ming Fu, MDf, Aruna Ganju, MDg, Robert Heary, MDh, Jose A. Herrera-Soto, MDi, A. Noelle Larson, MDj, William F. Lavelle, MDk, Ian W. Nelson, MDl, Alejo Vernengo-Lezica, MDm, Joseph M. Verska, MDn a
University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 3017, Kansas City, KS 66160-7387, USA St Louis University Medical Center, 3635 Vista Avenue at Grand Blvd., PO Box 15250, St Louis, MO 63110-0250, USA c Nebraska Spine Center, 13616 California Street, Omaha, NE 68154, USA d The Spine Hospital, New York Presbyterian/Allen, 5141 Broadway, 3FW-22, New York, NY 10034, USA e Shriners Hospital for Children Los Angeles, 3160 Geneva Street, Los Angeles, CA 90020, USA f Weill Cornell Medical College, 525 East 68th Street, Box 99, New York, NY 10065, USA g Northwestern Medical Faculty Foundation, 676 N. St. Clair, Suite 2210, Chicago, IL 60611, USA h Rutgers UniversityeNew Jersey Medical School, 90 Bergen Street Suite 8100, Newark, NJ 07103, USA i Arnold Palmer Hospital for Children, 1222 S. Orange Ave, 5th Floor, Orlando, FL 32806, USA j Mayo Clinic, Department of Orthopedic Surgery, 200 1st Street SW, Rochester, MN 55905, USA k SUNY Upstate Medical University, Upstate Orthopedics, 6620 Fly Road, Ste 200, East Syracuse, NY 13057, USA l Southmead Hospital, Department of Orthopaedic Surgery, Bristol BS10 5NB, United Kingdom m Sanatorio Mater DeieSan Isidro Hospital, Carlos Pellegrini 1277 2C, Buenos Aires, 1009 Argentina n Boise Spine Surgery, 8756 W. Emerald Street, Suite 176, Boise, ID 83704, USA Received 26 September 2015; revised 8 May 2016; accepted 28 May 2016
b
Abstract Introduction: Members of the Scoliosis Research Society are required to annually submit complication data regarding deaths, visual acuity loss, neurological deficit and infection (2012-1st year for this measure) for all deformity operations performed. The purpose of this study is to report the 2012 results and the differences in these complications from the years 2009-2012. Methods: The SRS M&M database is a self-reported complications registry of deformity operations performed by the members. The data from 2009-2012, inclusive, was tabulated and analyzed. Differences in frequency distribution between years were analyzed with Fisher’s exact test. Significance was set at a 5 0.05. Results: The total number of cases reported increased from 34,332 in 2009 to 47,755 in 2012. Overall mortality ranged from 0.07% in 2011 to 0.12% in 2009. The neuromuscular scoliosis group had the highest mortality rate (0.44%) in 2010. The combined groups’ neurological deficit rate increased from 0.44% in 2009 to 0.79% in 2012. Neurological deficits were significantly lower in 2009 compared to 2012 for idiopathic scoliosis O18 years, other scoliosis, degenerative and isthmic spondylolisthesis and other groups. The groups with the highest neurological deficit rates were dysplastic spondylolisthesis and congenital kyphosis. There were no differences in vision loss rates between years. The overall 2012 infection rate was 1.14% with neuromuscular scoliosis having the highest group rate at 2.97%. Author disclosures: DCB (personal fees from DePuy Spine, personal fees from DePuy Spine, from University of Kansas Physicians, Inc-Board of Directors, from International Spine Study Group-Board of Directors, other from DePuy Spine, outside the submitted work), BBC (none), HMP (grants from Scoliosis Research Society, outside the submitted work), JEF (none), KB (none), RC (other from DePuy Synthes Spine, other from Medtronic Sofamor Danek, other from Orthopediatrics, other from Ergobaby Inc., outside the submitted work), KMF (none), AG (none), Robert Heary (DePuy Synthes Spine Inc., Zimmer Spine Inc.droyalties), 2212-134X/$ - see front matter Ó 2016 Scoliosis Research Society. http://dx.doi.org/10.1016/j.jspd.2016.05.003
JAHS (other from Biomet Spine, outside the submitted work), ANL (grants from NIH, grants from Scoliosis Research Society, grants from Mayo Clinic Children’s Center, grants from Mayo Clinic Center for Regenerative Medicine, outside the submitted work), WFL (none), IWN (personal fees from De Puy, outside the submitted work), AVL (none), JMV (none). *Corresponding author. University of Kansas Medical Center, Department of Orthopedic Surgery, 3901 Rainbow Blvd, MS 3017, Kansas City KS 66160, USA. Tel.: (913) 588-6172; fax: (913) 588-0862. E-mail address: [email protected] (D.C. Burton).
D.C. Burton et al. / Spine Deformity 4 (2016) 338e343
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Conclusion: Neuromuscular scoliosis has the highest complication rates of mortality and infection. The neurological deficit rates of all groups combined have slightly increased from 2009 to 2012 with the highest rates consistently being in the dysplastic spondylolisthesis and congenital kyphosis groups. This could be due to a number of factors, including more rigorous reporting. Ó 2016 Scoliosis Research Society. Keywords: Complications; Neurologic deficit; Spinal Deformity
$300 fee. Information collected includes the total number of surgeries performed within each diagnostic group and more detailed information on any patients who sustained one of the four specified types of complications. Information is due by April 1 of the following year. Members may input data throughout the year or enter all information at the deadline. Deformity groups defined in the SRS M&M database include idiopathic scoliosis (IS) !10 years, IS 10e18 years, IS O 18 years, congenital scoliosis, neuromuscular scoliosis, other scoliosis, isthmic spondylolisthesis, degenerative spondylolisthesis, dysplastic spondylolisthesis, congenital kyphosis, Scheuermann kyphosis, other. Primary complications recorded include death, vision change, neurologic deficit, and infection (starting in 2012). Vision change included any deficit in vision, ranging from bilateral blindness to partial visual field loss. Neurologic deficit was reported in the database as root or cord level. If the injury was cord level, it was noted to be complete or incomplete. Only acute (within 90 days of surgery) infections were included in the infection category. Total tabulated case numbers and category complication rates were calculated. Differences in frequency distribution of complications between years within deformity groups were analyzed with the Fisher exact test. Differences between deformity groups were not calculated due to data being in aggregate form only. Data were analyzed with SPSS Statistics v21.0 (IBM Corp, Armonk, NY). Significance was set at a 5 0.05.
Introduction The Scoliosis Research Society (SRS) was organized in 1966 as the first subspecialty-specific society within the orthopedic field. Its founders sought to provide educational and research opportunities for their peers that care for spinal deformity patients. Since the third SRS meeting in 1968, members have been required to submit an annual complications report, known as the Morbidity and Mortality (M&M) report [1]. Initially, submission was performed with punch cards mailed to the SRS headquarters and remained that way into the 1990s. In the early to mid-1990s, computerized entry was introduced and more detailed surgical and complication data were requested. Complication reporting rates and compliance among the membership declined following this change. In 2009, the online system was modified to only request detailed information for patients with the following complications: death, blindness, and neurologic deficit. In 2012, acute infection was added to this list. The purpose of this study was to analyze the SRS M&M database and trends of complications among the membership in the treatment of patients with spinal deformity between 2009e2012. Materials and Methods SRS members self-report complications related to spinal deformity operations they perform. Complication reporting is required annually or members may opt out by paying a
Table 1 Year 2009 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
1,108 6,946 3,511 1,806 2,687 3,782 2,841 7,875 308 386 588 2,494 34,332
Deaths
Vision loss
Neurologic deficit
n
%
n
%
n
%
2 2 7 2 7 7 0 3 1 1 0 8 40
0.18 0.03 0.20 0.11 0.26 0.19 0.00 0.04 0.32 0.26 0.00 0.32 0.12
0 2 0 0 0 1 0 0 0 0 0 1 4
0.00 0.03 0.00 0.00 0.00 0.03 0.00 0.00 0.00 0.00 0.00 0.04 0.01
2 16 23 14 13 10 8 19 6 9 3 28 151
0.18 0.23 0.66 0.78 0.48 0.26 0.28 0.24 1.95 2.33 0.51 1.12 0.44
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular.
Cord level
Complete
2 9 21 9 5 6 n/a n/a n/a 6 2 16 76
0 0 0 4 3 2 n/a n/a n/a 0 0 4 13
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D.C. Burton et al. / Spine Deformity 4 (2016) 338e343
Table 2 Year 2010 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
Deaths
1,381 8,127 4,234 2,185 3,157 4,780 3,226 9,047 469 539 683 2,645 40,473
Vision loss
Neurologic deficit
n
%
n
%
n
%
0 1 3 4 14 13 0 2 0 1 1 9 48
0.00 0.01 0.07 0.18 0.44 0.27 0.00 0.02 0.00 0.19 0.15 0.34 0.14
1 0 2 0 0 0 1 2 0 1 0 2 9
0.01 0.00 0.09 0.00 0.00 0.00 0.01 0.43 0.00 0.15 0.00 0.00 0.06
2 19 31 17 5 16 17 26 5 7 5 29 179
0.14 0.23 0.73 0.78 0.16 0.33 0.53 0.29 1.07 1.30 0.73 1.10 0.62
Cord level
Complete
2 17 4 10 3 5 n/a n/a n/a 5 3 14 63
1 6 3 5 1 1 n/a n/a n/a 1 0 4 22
Cord level
Complete
3 17 6 13 10 7 n/a n/a n/a 10 1 26 93
0 5 0 1 3 6 n/a n/a n/a 2 1 8 26
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular. Table 3 Year 2011 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
Deaths
1,586 8,969 4,279 2,391 3,739 4,597 3,849 11,157 469 526 896 2,954 45,412
Vision loss
Neurologic deficit
n
%
n
%
n
%
0 0 8 2 3 10 0 6 0 0 1 2 32
0.00 0.00 0.19 0.08 0.08 0.22 0.00 0.05 0.00 0.00 0.11 0.07 0.07
0 1 1 0 0 0 0 0 0 0 1 2 5
0.00 0.01 0.02 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.11 0.07 0.02
4 33 64 22 18 14 18 55 4 14 4 39 289
0.25 0.37 1.50 0.92 0.48 0.30 0.47 0.49 0.85 2.66 0.45 1.32 0.84
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular. Table 4 Year 2012 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
Deaths
Vision loss
Neurologic deficit n
Cord level
Complete
Deep infections
Total infection
n
n
n
%
n
%
%
n
%
1,784 9,582 4,344 2,570 3,571 5,520 3,873
1 2 2 4 9 12 1
0.06 0.02 0.05 0.16 0.25 0.22 0.03
0 1 0 0 0 1 0
0.00 0.01 0.00 0.00 0.00 0.02 0.00
3 30 76 28 16 14 44
0.17 0.31 1.75 1.09 0.45 0.25 1.14
3 21 11 16 14 7 n/a
0 3 2 3 4 2 n/a
2 18 20 3 21 8 4
0.11 0.19 0.46 0.12 0.59 0.14 0.10
4 35 56 15 85 19 15
0.22 0.37 1.29 0.58 2.38 0.34 0.39
6 53 76 18 106 27 19
0.34 0.55 1.75 0.70 2.97 0.49 0.49
11,287
5
0.04
0
0.00
65
0.58
n/a
n/a
53
0.47
90
0.80
143
1.27
500
0
0.00
0
0.00
11
2.20
n/a
n/a
2
0.40
0
0.00
2
0.40
579 897 3,248 47,755
0 1 13 50
0.00 0.11 0.40 0.10
0 0 0 2
0.00 0.00 0.00 0.00
21 3 66 377
3.63 0.33 2.03 0.79
14 3 25 114
0 0 3 17
1 7 15 154
0.17 0.78 0.46 0.32
7 9 54 389
1.21 1.00 1.66 0.81
8 16 69 543
1.38 1.78 2.12 1.14
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular.
%
Superficial infections %
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Table 5 Trends in neurologic deficit by diagnosis. IS O 18 Year 1 2009 2009 2009 2010 2010 2011
NM Scoliosis Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
2010 2011 2012 2011 2012 2012
.784 .000 .000 .001 .000 .394
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
.032 1.000 .853 .021 .047 .865
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
.162 .241 .000 .737 .006 .001
Congenital kyphosis
Degenerative spondylolisthesis Year 1 2009 2009 2009 2010 2010 2011
Isthmic spondylolisthesis
Other
Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
2010 2011 2012 2011 2012 2012
.653 .007 .001 .026 .002 .411
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
.307 .833 .344 .126 .013 .394
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
1.000 .539 .008 .466 .005 .030
IS, idiopathic scoliosis; NM, neuromuscular. Significance was set at p ! .05.
Results The total number of cases reported increased from 34,332 in 2009 to 47,755 in 2012. In 2012, 92% of the SRS members completed their M&M requirement. Overall mortality ranged from 0.07% in 2011 to 0.12% in 2009. The neuromuscular scoliosis group had the highest group mortality rate (0.44%) in 2010. The only significant difference in mortality between years was from 2010 to 2011 in the neuromuscular scoliosis group (0.44% vs 0.08%; p 5 .0028) (Tables 1e4). The overall neurologic deficit rate increased yearly from 0.44% in 2009 to 0.79% in 2012. Neurologic deficits increased over the course of the years studied in idiopathic scoliosis O18 years, neuromuscular scoliosis, isthmic and degenerative spondylolisthesis, and Other groups (Table 5). The groups with the highest neurologic deficit rates were dysplastic spondylolisthesis and congenital kyphosis (Tables 1e4). Vision loss rates were less than 1% for all groups. The highest vision loss rate was 0.19% in the congenital kyphosis group during 2010. There were no differences in vision loss rates among years in any deformity group. The overall 2012 infection rate was 1.14%. Neuromuscular scoliosis had the highest infection rate of 2.97% (Tables 1e4). Discussion This paper reports the first four years of data from the SRS M&M database since changing to more specific reporting of the four complication categories in 2009. Overall, complication rates were consistent throughout the four years with the exception of neurologic deficit, which increased over the reporting period. The reason for this is unknown, but could be due to a number of reasons, including more accurate reporting.
Congenital kyphosis and dysplastic spondylolisthesis consistently had the highest neurologic complication rate. This is consistent with previously published reports. Yaszay et al. reported on 76 patients with congenital kyphosis treated surgically with a 7.8% neurologic complication rate [2,3]. These ranged from a postoperative seizure to profound lower extremity weakness. All of these patients had a full recovery. Likewise, Min et al. reported on 15 patients with dysplastic spondylolisthesis treated with a sacral dome osteotomy and noted 4 (27%) with a neurologic complication [4]. All of their patients’ symptoms resolved eventually. The rate of complications among the cohort of patients with Scheuermann kyphosis remained consistent throughout the study period. There was no report of visual field deficits, the neurologic deficit rate ranged from 0.33% to 0.73% and mortality ranged from 0% to 0.15%. A previous study of patients from the SRS M&M database from 2001 to 2004 reported on 683 patients with this diagnosis treated surgically and the neurologic deficit rate was 1.9% with a 0.6% mortality rate [5]. The current study, while reporting a lower complication rate, included more than 3600 patients, nearly six times the size of the previous report. Other authors have reported low mortality and neurologic deficit rates as well for Scheuermann kyphosis [6,7]. Among the adolescent idiopathic scoliosis (AIS) patients, complication rates remained consistent across the studied years. The total number of patients with this diagnosis treated over the four-year period was 33,624. The neurologic deficit rate ranged from 0.23% to 0.37% and the mortality ranged from 0% to 0.03%. Hwang et al. reported on 99 patients with AIS treated with pedicle screws, and there were no deaths in their series [8]. They reported seven
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patients with postoperative radicular symptoms that did not require surgical treatment. Larger studies of this patient population have reported low complication rates as well. A 2011 study of the SRS database reported on 11,000 patients with idiopathic scoliosis, combining infantile, juvenile, and adolescent patients treated from 2004 to 2007. They reported a neurologic deficit rate of 0.8% and a mortality of 0.02% [9]. A previous study of this same database from 2001 to 2003 studying only AIS reported a mortality rate of 0.03% and neurologic complication rate of 0.49% [10]. These numbers are consistent with our current rates with a patient population that was three times larger. The 13,154 patients with neuromuscular scoliosis had the highest mortality (mean 0.26%) and the highest infection (2.97%) rates among the diagnostic groups studied. This is similar to a previous study of the SRS M&M database in 2011 reporting a mortality rate of 0.3% and a combined deep and superficial infection rate of 5.5% among 4,657 patients [9]. Likewise, Sharma et al. performed a meta-analysis of the last 15 years’ literature and found a pooled neurologic complication rate of 3% (range 0%e61%) and a pooled infection rate of 10.9% (range 0%e46%) [10]. The primary concern of any study such as this is the accuracy and completeness of the data submitted. The information contained in this study was voluntarily submitted and no quality assurance was then made of the de-identified (patient and physician) data. Martin et al. recently reviewed National Surgical Quality Improvement Program (NSQIP) results from 50 pediatric hospitals in the United States for the incidence of wound complications in spinal arthrodesis in children and found good concordance between SRS M&M data and NSQIP data with respect to this complication [11]. Webb et al. studied the rates of postoperative infection reported in the SRS M&M database and compared to NSQIP for the years 2012 and 2013. The SRS rate was 1.21%, and the NSQIP rate, 1.85%. This difference was significant, but small, and differences existed only for the categories of Scheuermann kyphosis (5.49%), AIS ages 10e18 (1.10%), and adult scoliosis (1.28%). Differences were attributed to differences in data collection methods, and the conclusion was that SRS M&M data were reliable [12]. The Scoli-Risk study [13] is a prospective study evaluating patients undergoing complex adult spinal deformity surgery. They used a prospective collection protocol with trained American Spinal Injury Association (ASIA) ecertified examiners evaluating each patient and reported a neurologic complication rate higher (17%) than that found in retrospective studies [13]. There are several explanations for the vast difference in rates between the Scoli-Risk study and the SRS Database. The most obvious is underreporting in our cohort. The Scoli-Risk study enrolled patients undergoing much higher-risk surgeries than any one particular diagnostic group in our database, and this could also account for some of the difference. However, the neurologic deficit rates in this study, although consistent with previous retrospective reports in the literature, almost
certainly underestimate the true incidence of complications in these patients. This study reports the results of the first four years of data from the SRS M&M database since moving to a simplified reporting system. This represents information that is different from an administrative database, as the treating physicians have identified the diagnostic categories in which each patient belongs. However, the treating surgeon is responsible for reporting the complications, which is also different from an administrative database. Its primary weakness is the voluntary reporting format and lack of a quality assurance analysis, which limits the impact of the data. Other weaknesses include a lack of clear definitions of specific complications, possible recall bias for surgeons who submit all cases at year-end rather than on a continual basis, an inability to analyze cofactors or comorbidities that could explain differences among the cohort, an inability to analyze complication impact on cost and health-related quality of life, and a lack of long-term follow-up. The main strength is the sheer size of this cohort, with 168,907 cases reported over 4 years. In addition, the SRS membership size is increasing annually and there was a respective increase in cases reported and improvement in reporting rates over the same period. This database still provides important global complication data across a massive cohort of spinal deformity patients. Conclusions The Scoliosis Research Society Morbidity and Mortality database had 168,907 cases reported between 2009 and 2012 by 716 of its 782 members (92%). Membership, reporting rates, and total number of cases all increased each year over the study period. Neuromuscular scoliosis cases had the highest mortality and infection rates. Neurologic deficit rates showed an increasing trend over the four-year study period and occurred most frequently in congenital kyphosis and dysplastic spondylolisthesis cases. The principal benefit of the SRS M&M database is that it is a large cohort registry, which aids in quantifying global complication rates among spinal deformity patients. Key Points The neuromuscular scoliosis group had the highest mortality rate. The highest rate of neurologic deficit occurred in the dysplastic spondylolisthesis and congenital scoliosis groups. The neuromuscular scoliosis group had the highest infection rate.
Acknowledgments Arlensiu Novelli Committee Liasons.
and
Nilda
Toro,
SRS
M&M
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References [1] SRS Archives. Clendening Library. Kansas University Medical Center. Kansas City, KS (In press). [2] Yaszay B, O’Brien M, Shufflebarger H, et al. Efficacy of hemivertebra resection for congenital scoliosis. Spine 2011;36:2052e60. [3] Min K, Liebscher T, Rothenfluh D. Sacral dome resection and singlestage posterior reduction in the treatment of high-grade high dysplastic spondylolisthesis in adolescents and young adults. Eur Spine J 2012;(Suppl 6):S785e91. [4] Coe J, Smith J, Berven S, et al. Complications of spinal fusion for Scheuermann’s kyphosis: a report of the SRS M&M Committee. Spine 2009;35:99e103. [5] Lonner B, Newton P, Betz R, et al. Operative management of Scheuermann’s kyphosis in 78 patients. Spine 2007;32:2644e52. [6] Koller H, Juliane Z, Umstaetter M, et al. Surgical treatment of Scheuermann’s kyphosis using a combined antero-posterior strategy and pedicle screw constructs: efficacy, radiographic and clinical outcomes in 111 cases. Eur Spine J 2014;23:180e91. [7] Hwang S, Samdani A, Marks M, et al. Five-year clinical and radiographic outcomes using pedicle screw only constructs in the treatment of adolescent idiopathic scoliosis. Eur Spine J 2013;22:1292e9.
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[8] Reames D, Smith J, Fu K, et al. Complications in the surgical treatment of 19,360 cases of pediatric scoliosis: a review of the SRS M&M database. Spine 2011;36:1484e91. [9] Coe J, Arlet V, Donaldson W, et al. Complications in spinal fusion for adolescent idiopathic scoliosis in the new millennium. A report of the Scoliosis Research Society Morbidity and Mortality Committee. Spine 2006;31:345e9. [10] Sharma S, Wu C, Andersen T, et al. Prevalence of complications in neuromuscular scoliosis surgery: a literature meta-analysis from the past 15 years. Eur Spine J 2013;22:1230e49. [11] Martin C, Pugely A, Goa Y, et al. Incidence and risk factors for early wound complications after spinal arthrodesis in children: analysis of 30-day follow-up data from the ACS-NSQIP. Spine 2014;39: 1463e70. [12] Webb M, Lukasiewicz AM, Samuel AM, et al. Overall similar infection rates reported in the physician-reported Scoliosis Research Society Database and the Chart-abstracted American College of Surgeons National Surgical Quality Improvement Program Database. Spine 2015;40:1431e5. [13] Lenke L, Fehlings M, Shaffrey C, et al. Prospective, multi-center assessment of acute neurologic complications following complex adult spinal deformity surgery: the Scoli-Risk-1 Trial. Scoliosis Research Society Annual Meeting. September 18-21, 2013. Lyon, France.
Results of the Scoliosis Research Society Morbidity and Mortality Database 2009e2012: A Report From the Morbidity and Mortality Committee Douglas C. Burton, MDa,*, Brandon B. Carlson, MDa, Howard M. Place, MDb, Jonathan E. Fuller, MDc, Kathy Blanke, RNd, Robert Cho, MDe, Kai-Ming Fu, MDf, Aruna Ganju, MDg, Robert Heary, MDh, Jose A. Herrera-Soto, MDi, A. Noelle Larson, MDj, William F. Lavelle, MDk, Ian W. Nelson, MDl, Alejo Vernengo-Lezica, MDm, Joseph M. Verska, MDn a
University of Kansas Medical Center, 3901 Rainbow Boulevard, MS 3017, Kansas City, KS 66160-7387, USA St Louis University Medical Center, 3635 Vista Avenue at Grand Blvd., PO Box 15250, St Louis, MO 63110-0250, USA c Nebraska Spine Center, 13616 California Street, Omaha, NE 68154, USA d The Spine Hospital, New York Presbyterian/Allen, 5141 Broadway, 3FW-22, New York, NY 10034, USA e Shriners Hospital for Children Los Angeles, 3160 Geneva Street, Los Angeles, CA 90020, USA f Weill Cornell Medical College, 525 East 68th Street, Box 99, New York, NY 10065, USA g Northwestern Medical Faculty Foundation, 676 N. St. Clair, Suite 2210, Chicago, IL 60611, USA h Rutgers UniversityeNew Jersey Medical School, 90 Bergen Street Suite 8100, Newark, NJ 07103, USA i Arnold Palmer Hospital for Children, 1222 S. Orange Ave, 5th Floor, Orlando, FL 32806, USA j Mayo Clinic, Department of Orthopedic Surgery, 200 1st Street SW, Rochester, MN 55905, USA k SUNY Upstate Medical University, Upstate Orthopedics, 6620 Fly Road, Ste 200, East Syracuse, NY 13057, USA l Southmead Hospital, Department of Orthopaedic Surgery, Bristol BS10 5NB, United Kingdom m Sanatorio Mater DeieSan Isidro Hospital, Carlos Pellegrini 1277 2C, Buenos Aires, 1009 Argentina n Boise Spine Surgery, 8756 W. Emerald Street, Suite 176, Boise, ID 83704, USA Received 26 September 2015; revised 8 May 2016; accepted 28 May 2016
b
Abstract Introduction: Members of the Scoliosis Research Society are required to annually submit complication data regarding deaths, visual acuity loss, neurological deficit and infection (2012-1st year for this measure) for all deformity operations performed. The purpose of this study is to report the 2012 results and the differences in these complications from the years 2009-2012. Methods: The SRS M&M database is a self-reported complications registry of deformity operations performed by the members. The data from 2009-2012, inclusive, was tabulated and analyzed. Differences in frequency distribution between years were analyzed with Fisher’s exact test. Significance was set at a 5 0.05. Results: The total number of cases reported increased from 34,332 in 2009 to 47,755 in 2012. Overall mortality ranged from 0.07% in 2011 to 0.12% in 2009. The neuromuscular scoliosis group had the highest mortality rate (0.44%) in 2010. The combined groups’ neurological deficit rate increased from 0.44% in 2009 to 0.79% in 2012. Neurological deficits were significantly lower in 2009 compared to 2012 for idiopathic scoliosis O18 years, other scoliosis, degenerative and isthmic spondylolisthesis and other groups. The groups with the highest neurological deficit rates were dysplastic spondylolisthesis and congenital kyphosis. There were no differences in vision loss rates between years. The overall 2012 infection rate was 1.14% with neuromuscular scoliosis having the highest group rate at 2.97%. Author disclosures: DCB (personal fees from DePuy Spine, personal fees from DePuy Spine, from University of Kansas Physicians, Inc-Board of Directors, from International Spine Study Group-Board of Directors, other from DePuy Spine, outside the submitted work), BBC (none), HMP (grants from Scoliosis Research Society, outside the submitted work), JEF (none), KB (none), RC (other from DePuy Synthes Spine, other from Medtronic Sofamor Danek, other from Orthopediatrics, other from Ergobaby Inc., outside the submitted work), KMF (none), AG (none), Robert Heary (DePuy Synthes Spine Inc., Zimmer Spine Inc.droyalties), 2212-134X/$ - see front matter Ó 2016 Scoliosis Research Society. http://dx.doi.org/10.1016/j.jspd.2016.05.003
JAHS (other from Biomet Spine, outside the submitted work), ANL (grants from NIH, grants from Scoliosis Research Society, grants from Mayo Clinic Children’s Center, grants from Mayo Clinic Center for Regenerative Medicine, outside the submitted work), WFL (none), IWN (personal fees from De Puy, outside the submitted work), AVL (none), JMV (none). *Corresponding author. University of Kansas Medical Center, Department of Orthopedic Surgery, 3901 Rainbow Blvd, MS 3017, Kansas City KS 66160, USA. Tel.: (913) 588-6172; fax: (913) 588-0862. E-mail address: [email protected] (D.C. Burton).
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Conclusion: Neuromuscular scoliosis has the highest complication rates of mortality and infection. The neurological deficit rates of all groups combined have slightly increased from 2009 to 2012 with the highest rates consistently being in the dysplastic spondylolisthesis and congenital kyphosis groups. This could be due to a number of factors, including more rigorous reporting. Ó 2016 Scoliosis Research Society. Keywords: Complications; Neurologic deficit; Spinal Deformity
$300 fee. Information collected includes the total number of surgeries performed within each diagnostic group and more detailed information on any patients who sustained one of the four specified types of complications. Information is due by April 1 of the following year. Members may input data throughout the year or enter all information at the deadline. Deformity groups defined in the SRS M&M database include idiopathic scoliosis (IS) !10 years, IS 10e18 years, IS O 18 years, congenital scoliosis, neuromuscular scoliosis, other scoliosis, isthmic spondylolisthesis, degenerative spondylolisthesis, dysplastic spondylolisthesis, congenital kyphosis, Scheuermann kyphosis, other. Primary complications recorded include death, vision change, neurologic deficit, and infection (starting in 2012). Vision change included any deficit in vision, ranging from bilateral blindness to partial visual field loss. Neurologic deficit was reported in the database as root or cord level. If the injury was cord level, it was noted to be complete or incomplete. Only acute (within 90 days of surgery) infections were included in the infection category. Total tabulated case numbers and category complication rates were calculated. Differences in frequency distribution of complications between years within deformity groups were analyzed with the Fisher exact test. Differences between deformity groups were not calculated due to data being in aggregate form only. Data were analyzed with SPSS Statistics v21.0 (IBM Corp, Armonk, NY). Significance was set at a 5 0.05.
Introduction The Scoliosis Research Society (SRS) was organized in 1966 as the first subspecialty-specific society within the orthopedic field. Its founders sought to provide educational and research opportunities for their peers that care for spinal deformity patients. Since the third SRS meeting in 1968, members have been required to submit an annual complications report, known as the Morbidity and Mortality (M&M) report [1]. Initially, submission was performed with punch cards mailed to the SRS headquarters and remained that way into the 1990s. In the early to mid-1990s, computerized entry was introduced and more detailed surgical and complication data were requested. Complication reporting rates and compliance among the membership declined following this change. In 2009, the online system was modified to only request detailed information for patients with the following complications: death, blindness, and neurologic deficit. In 2012, acute infection was added to this list. The purpose of this study was to analyze the SRS M&M database and trends of complications among the membership in the treatment of patients with spinal deformity between 2009e2012. Materials and Methods SRS members self-report complications related to spinal deformity operations they perform. Complication reporting is required annually or members may opt out by paying a
Table 1 Year 2009 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
1,108 6,946 3,511 1,806 2,687 3,782 2,841 7,875 308 386 588 2,494 34,332
Deaths
Vision loss
Neurologic deficit
n
%
n
%
n
%
2 2 7 2 7 7 0 3 1 1 0 8 40
0.18 0.03 0.20 0.11 0.26 0.19 0.00 0.04 0.32 0.26 0.00 0.32 0.12
0 2 0 0 0 1 0 0 0 0 0 1 4
0.00 0.03 0.00 0.00 0.00 0.03 0.00 0.00 0.00 0.00 0.00 0.04 0.01
2 16 23 14 13 10 8 19 6 9 3 28 151
0.18 0.23 0.66 0.78 0.48 0.26 0.28 0.24 1.95 2.33 0.51 1.12 0.44
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular.
Cord level
Complete
2 9 21 9 5 6 n/a n/a n/a 6 2 16 76
0 0 0 4 3 2 n/a n/a n/a 0 0 4 13
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Table 2 Year 2010 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
Deaths
1,381 8,127 4,234 2,185 3,157 4,780 3,226 9,047 469 539 683 2,645 40,473
Vision loss
Neurologic deficit
n
%
n
%
n
%
0 1 3 4 14 13 0 2 0 1 1 9 48
0.00 0.01 0.07 0.18 0.44 0.27 0.00 0.02 0.00 0.19 0.15 0.34 0.14
1 0 2 0 0 0 1 2 0 1 0 2 9
0.01 0.00 0.09 0.00 0.00 0.00 0.01 0.43 0.00 0.15 0.00 0.00 0.06
2 19 31 17 5 16 17 26 5 7 5 29 179
0.14 0.23 0.73 0.78 0.16 0.33 0.53 0.29 1.07 1.30 0.73 1.10 0.62
Cord level
Complete
2 17 4 10 3 5 n/a n/a n/a 5 3 14 63
1 6 3 5 1 1 n/a n/a n/a 1 0 4 22
Cord level
Complete
3 17 6 13 10 7 n/a n/a n/a 10 1 26 93
0 5 0 1 3 6 n/a n/a n/a 2 1 8 26
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular. Table 3 Year 2011 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
Deaths
1,586 8,969 4,279 2,391 3,739 4,597 3,849 11,157 469 526 896 2,954 45,412
Vision loss
Neurologic deficit
n
%
n
%
n
%
0 0 8 2 3 10 0 6 0 0 1 2 32
0.00 0.00 0.19 0.08 0.08 0.22 0.00 0.05 0.00 0.00 0.11 0.07 0.07
0 1 1 0 0 0 0 0 0 0 1 2 5
0.00 0.01 0.02 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.11 0.07 0.02
4 33 64 22 18 14 18 55 4 14 4 39 289
0.25 0.37 1.50 0.92 0.48 0.30 0.47 0.49 0.85 2.66 0.45 1.32 0.84
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular. Table 4 Year 2012 data. Total
IS ! 10 IS 10e18 IS O 18 Congenital scoliosis NM scoliosis Other scoliosis Isthmic spondylolisthesis Degenerative spondylolisthesis Dysplastic spondylolisthesis Congenital kyphosis Scheuermann kyphosis Other Total
Deaths
Vision loss
Neurologic deficit n
Cord level
Complete
Deep infections
Total infection
n
n
n
%
n
%
%
n
%
1,784 9,582 4,344 2,570 3,571 5,520 3,873
1 2 2 4 9 12 1
0.06 0.02 0.05 0.16 0.25 0.22 0.03
0 1 0 0 0 1 0
0.00 0.01 0.00 0.00 0.00 0.02 0.00
3 30 76 28 16 14 44
0.17 0.31 1.75 1.09 0.45 0.25 1.14
3 21 11 16 14 7 n/a
0 3 2 3 4 2 n/a
2 18 20 3 21 8 4
0.11 0.19 0.46 0.12 0.59 0.14 0.10
4 35 56 15 85 19 15
0.22 0.37 1.29 0.58 2.38 0.34 0.39
6 53 76 18 106 27 19
0.34 0.55 1.75 0.70 2.97 0.49 0.49
11,287
5
0.04
0
0.00
65
0.58
n/a
n/a
53
0.47
90
0.80
143
1.27
500
0
0.00
0
0.00
11
2.20
n/a
n/a
2
0.40
0
0.00
2
0.40
579 897 3,248 47,755
0 1 13 50
0.00 0.11 0.40 0.10
0 0 0 2
0.00 0.00 0.00 0.00
21 3 66 377
3.63 0.33 2.03 0.79
14 3 25 114
0 0 3 17
1 7 15 154
0.17 0.78 0.46 0.32
7 9 54 389
1.21 1.00 1.66 0.81
8 16 69 543
1.38 1.78 2.12 1.14
IS, idiopathic scoliosis; n/a, not applicable; NM, neuromuscular.
%
Superficial infections %
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Table 5 Trends in neurologic deficit by diagnosis. IS O 18 Year 1 2009 2009 2009 2010 2010 2011
NM Scoliosis Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
2010 2011 2012 2011 2012 2012
.784 .000 .000 .001 .000 .394
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
.032 1.000 .853 .021 .047 .865
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
.162 .241 .000 .737 .006 .001
Congenital kyphosis
Degenerative spondylolisthesis Year 1 2009 2009 2009 2010 2010 2011
Isthmic spondylolisthesis
Other
Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
Year 1
Year 2
Fisher exact (p value)
2010 2011 2012 2011 2012 2012
.653 .007 .001 .026 .002 .411
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
.307 .833 .344 .126 .013 .394
2009 2009 2009 2010 2010 2011
2010 2011 2012 2011 2012 2012
1.000 .539 .008 .466 .005 .030
IS, idiopathic scoliosis; NM, neuromuscular. Significance was set at p ! .05.
Results The total number of cases reported increased from 34,332 in 2009 to 47,755 in 2012. In 2012, 92% of the SRS members completed their M&M requirement. Overall mortality ranged from 0.07% in 2011 to 0.12% in 2009. The neuromuscular scoliosis group had the highest group mortality rate (0.44%) in 2010. The only significant difference in mortality between years was from 2010 to 2011 in the neuromuscular scoliosis group (0.44% vs 0.08%; p 5 .0028) (Tables 1e4). The overall neurologic deficit rate increased yearly from 0.44% in 2009 to 0.79% in 2012. Neurologic deficits increased over the course of the years studied in idiopathic scoliosis O18 years, neuromuscular scoliosis, isthmic and degenerative spondylolisthesis, and Other groups (Table 5). The groups with the highest neurologic deficit rates were dysplastic spondylolisthesis and congenital kyphosis (Tables 1e4). Vision loss rates were less than 1% for all groups. The highest vision loss rate was 0.19% in the congenital kyphosis group during 2010. There were no differences in vision loss rates among years in any deformity group. The overall 2012 infection rate was 1.14%. Neuromuscular scoliosis had the highest infection rate of 2.97% (Tables 1e4). Discussion This paper reports the first four years of data from the SRS M&M database since changing to more specific reporting of the four complication categories in 2009. Overall, complication rates were consistent throughout the four years with the exception of neurologic deficit, which increased over the reporting period. The reason for this is unknown, but could be due to a number of reasons, including more accurate reporting.
Congenital kyphosis and dysplastic spondylolisthesis consistently had the highest neurologic complication rate. This is consistent with previously published reports. Yaszay et al. reported on 76 patients with congenital kyphosis treated surgically with a 7.8% neurologic complication rate [2,3]. These ranged from a postoperative seizure to profound lower extremity weakness. All of these patients had a full recovery. Likewise, Min et al. reported on 15 patients with dysplastic spondylolisthesis treated with a sacral dome osteotomy and noted 4 (27%) with a neurologic complication [4]. All of their patients’ symptoms resolved eventually. The rate of complications among the cohort of patients with Scheuermann kyphosis remained consistent throughout the study period. There was no report of visual field deficits, the neurologic deficit rate ranged from 0.33% to 0.73% and mortality ranged from 0% to 0.15%. A previous study of patients from the SRS M&M database from 2001 to 2004 reported on 683 patients with this diagnosis treated surgically and the neurologic deficit rate was 1.9% with a 0.6% mortality rate [5]. The current study, while reporting a lower complication rate, included more than 3600 patients, nearly six times the size of the previous report. Other authors have reported low mortality and neurologic deficit rates as well for Scheuermann kyphosis [6,7]. Among the adolescent idiopathic scoliosis (AIS) patients, complication rates remained consistent across the studied years. The total number of patients with this diagnosis treated over the four-year period was 33,624. The neurologic deficit rate ranged from 0.23% to 0.37% and the mortality ranged from 0% to 0.03%. Hwang et al. reported on 99 patients with AIS treated with pedicle screws, and there were no deaths in their series [8]. They reported seven
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patients with postoperative radicular symptoms that did not require surgical treatment. Larger studies of this patient population have reported low complication rates as well. A 2011 study of the SRS database reported on 11,000 patients with idiopathic scoliosis, combining infantile, juvenile, and adolescent patients treated from 2004 to 2007. They reported a neurologic deficit rate of 0.8% and a mortality of 0.02% [9]. A previous study of this same database from 2001 to 2003 studying only AIS reported a mortality rate of 0.03% and neurologic complication rate of 0.49% [10]. These numbers are consistent with our current rates with a patient population that was three times larger. The 13,154 patients with neuromuscular scoliosis had the highest mortality (mean 0.26%) and the highest infection (2.97%) rates among the diagnostic groups studied. This is similar to a previous study of the SRS M&M database in 2011 reporting a mortality rate of 0.3% and a combined deep and superficial infection rate of 5.5% among 4,657 patients [9]. Likewise, Sharma et al. performed a meta-analysis of the last 15 years’ literature and found a pooled neurologic complication rate of 3% (range 0%e61%) and a pooled infection rate of 10.9% (range 0%e46%) [10]. The primary concern of any study such as this is the accuracy and completeness of the data submitted. The information contained in this study was voluntarily submitted and no quality assurance was then made of the de-identified (patient and physician) data. Martin et al. recently reviewed National Surgical Quality Improvement Program (NSQIP) results from 50 pediatric hospitals in the United States for the incidence of wound complications in spinal arthrodesis in children and found good concordance between SRS M&M data and NSQIP data with respect to this complication [11]. Webb et al. studied the rates of postoperative infection reported in the SRS M&M database and compared to NSQIP for the years 2012 and 2013. The SRS rate was 1.21%, and the NSQIP rate, 1.85%. This difference was significant, but small, and differences existed only for the categories of Scheuermann kyphosis (5.49%), AIS ages 10e18 (1.10%), and adult scoliosis (1.28%). Differences were attributed to differences in data collection methods, and the conclusion was that SRS M&M data were reliable [12]. The Scoli-Risk study [13] is a prospective study evaluating patients undergoing complex adult spinal deformity surgery. They used a prospective collection protocol with trained American Spinal Injury Association (ASIA) ecertified examiners evaluating each patient and reported a neurologic complication rate higher (17%) than that found in retrospective studies [13]. There are several explanations for the vast difference in rates between the Scoli-Risk study and the SRS Database. The most obvious is underreporting in our cohort. The Scoli-Risk study enrolled patients undergoing much higher-risk surgeries than any one particular diagnostic group in our database, and this could also account for some of the difference. However, the neurologic deficit rates in this study, although consistent with previous retrospective reports in the literature, almost
certainly underestimate the true incidence of complications in these patients. This study reports the results of the first four years of data from the SRS M&M database since moving to a simplified reporting system. This represents information that is different from an administrative database, as the treating physicians have identified the diagnostic categories in which each patient belongs. However, the treating surgeon is responsible for reporting the complications, which is also different from an administrative database. Its primary weakness is the voluntary reporting format and lack of a quality assurance analysis, which limits the impact of the data. Other weaknesses include a lack of clear definitions of specific complications, possible recall bias for surgeons who submit all cases at year-end rather than on a continual basis, an inability to analyze cofactors or comorbidities that could explain differences among the cohort, an inability to analyze complication impact on cost and health-related quality of life, and a lack of long-term follow-up. The main strength is the sheer size of this cohort, with 168,907 cases reported over 4 years. In addition, the SRS membership size is increasing annually and there was a respective increase in cases reported and improvement in reporting rates over the same period. This database still provides important global complication data across a massive cohort of spinal deformity patients. Conclusions The Scoliosis Research Society Morbidity and Mortality database had 168,907 cases reported between 2009 and 2012 by 716 of its 782 members (92%). Membership, reporting rates, and total number of cases all increased each year over the study period. Neuromuscular scoliosis cases had the highest mortality and infection rates. Neurologic deficit rates showed an increasing trend over the four-year study period and occurred most frequently in congenital kyphosis and dysplastic spondylolisthesis cases. The principal benefit of the SRS M&M database is that it is a large cohort registry, which aids in quantifying global complication rates among spinal deformity patients. Key Points The neuromuscular scoliosis group had the highest mortality rate. The highest rate of neurologic deficit occurred in the dysplastic spondylolisthesis and congenital scoliosis groups. The neuromuscular scoliosis group had the highest infection rate.
Acknowledgments Arlensiu Novelli Committee Liasons.
and
Nilda
Toro,
SRS
M&M
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